[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-resuscitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-resuscitation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,89,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100581383","manual-t-piece-versus-ventilator-positive-pressure-ventilation-during-resuscitation-of-extremely-premature-neonates-100581383",false,"NCT06849596","Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates","A Cluster Crossover Randomized Controlled Trial of Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates: The MVP Trial","MVP","Inclusion Criteria::\n\n* GA 25+0 to 28+6 weeks using the best available obstetrical estimate\n* Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care\n* Received PPV as determined by the resuscitation team during the first 10 minutes of birth\n\nExclusion Criteria:\n\n* Outborn birth status\n* Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward)\n* Known major congenital or chromosomal anomaly\n* Established spontaneous respiration without receipt of PPV","ALL","25 Weeks","29 Weeks",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"NA","Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.",[28,29],"Neonatal Resuscitation","Apnea Neonatal",[31,32,33,34,35,36,37],"Premature Infant","Preterm Neonates","Oxygen","Lung Injury","Respiration, Artificial","Resuscitation","Ventilator, Mechanical","RECRUITING","2026-06-09",{"date":41,"type":42},"2026-06-11","ACTUAL",{"date":44,"type":42},"2025-12-01",{"date":46,"type":22},"2029-01-01",{"name":48,"class":49},"Michelle Baczynski","OTHER",10,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":73,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100625192","supraglottic-airway-for-resuscitation-in-preemies-100625192","NCT07419438","Supraglottic Airway for Resuscitation in Preemies","Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial","SUPREEMIE","Inclusion Criteria:\n\n* Gestational age 29 0\u002F7 to 33 6\u002F7 weeks at birth\n* Estimated fetal weight \\>\u002F= 1000 grams at birth\n* Clinical decision to initiate PPV\n* Parental informed consent\n\nExclusion Criteria:\n\n* Major anomalies or aneuploidy\n* Palliative care planned or considered\n* Not resuscitated in the infant resuscitation room","0 Days","1 Day",{"count":62,"type":22},20,[25],"The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0\u002F7 and 33 6\u002F7 weeks' gestation who require PPV at birth.\n\nThe main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0\u002F7 to 33 6\u002F7 weeks' gestation premature infants?\n\nParticipants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.",[66,67,68,69,28,70,71,72],"Respiratory Failure","Premature Neonates","Delivery Room Resuscitation","Positive Pressure Ventilation","Supraglottic Airway","Laryngeal Mask","Laryngeal Mask Airways",[74,75,68,76,77,70,78,72],"Respiratory failure","Premature neonates","Positive pressure ventilation","Neonatal resuscitation","laryngeal mask","2026-04-16",{"date":81,"type":42},"2026-04-17",{"date":83,"type":42},"2026-03-13",{"date":85,"type":22},"2026-10",{"name":87,"class":49},"University of Pennsylvania",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100604546","supraglottic-airway-for-resuscitation-trial-100604546","NCT07150923","Supraglottic Airway for Resuscitation Trial","Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation","SUGAR","Population 1: Hospital Staff\n\nPopulation 1a: Clinical providers and administrators who complete study questionnaires\n\nClinical provider 1a inclusion criteria:\n\n* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation\n* Fluent in English\n\nAdministrator 1a inclusion criteria\n\n* Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)\n* Fluent in English\n\nClinical provider and administrator exclusion 1a criteria: No exclusion criteria\n\nPopulation 1b: Clinical providers who participate in qualitative interviews\n\nClinical provider 1b inclusion criteria:\n\n* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation\n* Fluent in English\n\nClinical provider 1b exclusion criteria: No exclusion criteria\n\nPopulation 2: Patients who receive neonatal resuscitation at birth\n\nInclusion Criteria:\n\n* Inborn (not transferred to the hospital after birth)\n* ≥34 weeks' gestation at birth, based on best obstetrical estimate\n* Received PPV during neonatal resuscitation (as per provider's clinical assessment)\n\nExclusion Criteria:\n\n* Congenital diaphragmatic hernia\n* Airway anomalies",{"count":98,"type":22},36503,[25],"This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation, with a focus on implementation outcomes.",[28,68,69,102,70,72,103],"Infant, Newborn","Implementation Research",[28,68,76,70,72,103,102],"2026-02-26",{"date":107,"type":42},"2026-02-27",{"date":109,"type":42},"2026-01-01",{"date":111,"type":22},"2029-09",{"name":113,"class":49},"Children's Hospital of Philadelphia",30,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":88},"100610508","comparative-study-of-simulation-technologies-for-use-in-neonatal-resuscitation-training-for-rural-hospitals-100610508","NCT07228494","Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals","Inclusion Criteria:\n\n* at least 18 years of age\n* primary clinical role is either physicians, nurses, or respiratory therapists\n* have completed NRP® certification within the two years prior to enrollment\n* attend deliveries at participating hospital in study\n\nExclusion Criteria:\n\n\\- chronic neck pain, a previous neck injury that requires ongoing precautions, severe motion sickness or vertigo, and\u002For photosensitive epilepsy","18 Years",{"count":123,"type":22},400,[25],"Conduct a randomized cluster non-inferiority clinical trial with teams of interprofessional neonatal clinicians from rural delivery hospitals. In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology.",[127,28,128],"Interprofessional Education","Rural Health",[130,77,131,132,133,134,135],"HoloBaby","interprofessional education","medical education","neonatal readiness","technology development","mixed reality","NOT_YET_RECRUITING","2026-01-12",{"date":139,"type":42},"2026-01-13",{"date":141,"type":22},"2026-01-08",{"date":143,"type":22},"2028-12-31",{"name":145,"class":49},"MaineHealth"]